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To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib vaccine. This DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Single group study. Subjects in GSK Biologicals' rotavirus study (Rota-028) in Singapore will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infanrix Hexa Group | Experimental | Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028 (NCT00197210), additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTPa-HBV-IPV/Hib | Biological | 1 intramuscular injection (3rd study vaccine dose) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Any Solicited Local Symptoms | Assessed solicited local and general symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. | During the 4-day (Days 0-3) post-vaccination period following each dose and across doses |
| Number of Subjects Reporting Any Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. | During the 4-day (Days 0-3) post-vaccination period following each dose and across doses |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Singapore | 119074 | Singapore | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21323176 | Background | Lim FS, Phua KB, Lee BW, Quak SH, Teoh YL, Ramakrishnan G, Han HH, Van Der Meeren O, Jacquets JM, Bock HL. Safety and reactogenicity of DTPa-HBV-IPV/Hib and DTPa-IPV/I-Hib vaccines in a post-marketing surveillance setting. Southeast Asian J Trop Med Public Health. 2011 Jan;42(1):138-47. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 217744/100 | Informed Consent Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Infanrix Hexa Group | Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix in study 444563/028, additionally received 2 doses of Infanrix-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix-IPV/Hib vaccine (at 18 months of age). The Infanrix-IPV/Hib and Infanrix Hexa vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix vaccine was given orally. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| DTPa-IPV/Hib vaccine | Biological | 3 intramuscular injections (1st, 2nd and 4th vaccine dose) |
|
| During the 31-day (Days 0-30) post-vaccination period |
| Number of Subjects Reporting Any Large Swelling Reactions | A large swelling reaction was defined as swelling with a diameter greater than (>) 50 millimeters (mm), noticeable diffuse swelling or noticeable increase of limb circumference. | At Month 15, post-booster dose |
| Number of Subjects Reporting Any Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | During the entire study period (from Month 0 up to Month 21) |
| Singapore |
| 228510 |
| Singapore |
| GSK Investigational Site | Singapore | 229899 | Singapore |
For additional information about this study please refer to the GSK Clinical Study Register |
| 217744/100 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 217744/100 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 217744/100 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 217744/100 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 217744/100 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Infanrix Hexa Group | Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix in study 444563/028, additionally received 2 doses of Infanrix-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix-IPV/Hib vaccine (at 18 months of age). The Infanrix-IPV/Hib and Infanrix Hexa vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix vaccine was given orally. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Weeks |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Reporting Any Solicited Local Symptoms | Assessed solicited local and general symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and who filled in their symptom sheet. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) post-vaccination period following each dose and across doses |
|
|
| ||||||||||||||||||||||||||||
| Primary | Number of Subjects Reporting Any Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and who filled in their symptom sheet. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) post-vaccination period following each dose and across doses |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 31-day (Days 0-30) post-vaccination period |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Any Large Swelling Reactions | A large swelling reaction was defined as swelling with a diameter greater than (>) 50 millimeters (mm), noticeable diffuse swelling or noticeable increase of limb circumference. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | At Month 15, post-booster dose |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the entire study period (from Month 0 up to Month 21) |
|
|
Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Infanrix Hexa Group | Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix in study 444563/028, additionally received 2 doses of Infanrix-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix-IPV/Hib vaccine (at 18 months of age). The Infanrix-IPV/Hib and Infanrix Hexa vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix vaccine was given orally. | 0 | 702 | 108 | 702 | 594 | 702 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Head injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Foreign body trauma | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Inguinal hernia, obstructive | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Stag horn calculus | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Urticaria papular | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Gastritis viral | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Kawasaki's disease | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Abscess neck | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Exanthema subitum | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Herpangina | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Viral skin infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA 11.0 | Systematic Assessment | This solicited local symptom was only collected from subjects with their symptom sheets completed. |
|
| Redness | General disorders | MedDRA 11.0 | Systematic Assessment | This solicited local symptom was only collected from subjects with their symptom sheets completed. |
|
| Swelling | General disorders | MedDRA 11.0 | Systematic Assessment | This solicited local symptom was only collected from subjects with their symptom sheets completed. |
|
| Drowsiness | General disorders | MedDRA 11.0 | Systematic Assessment | This solicited general symptom was only collected from subjects with their symptom sheets completed. |
|
| Fever (Axillary) (°C) | General disorders | MedDRA 11.0 | Systematic Assessment | This solicited general symptom was only collected from subjects with their symptom sheets completed. |
|
| Irritability | General disorders | MedDRA 11.0 | Systematic Assessment | This solicited general symptom was only collected from subjects with their symptom sheets completed. |
|
| Loss of appetite | General disorders | MedDRA 11.0 | Systematic Assessment | This solicited general symptom was only collected from subjects with their symptom sheets completed. |
|
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D006192 | Haemophilus Infections |
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D003015 | Clostridium Infections |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
Not provided
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| Not specified |
|
| Chinese |
|
| Malay |
|
| Indian |
|
|
| Any Swelling, Dose 1 |
|
|
| Any Pain, Dose 2 |
|
|
| Any Redness, Dose 2 |
|
|
| Any Swelling, Dose 2 |
|
|
| Any Pain, Dose 3 |
|
|
| Any Redness, Dose 3 |
|
|
| Any Swelling, Dose 3 |
|
|
| Any Pain, Booster dose |
|
|
| Any Redness, Booster dose |
|
|
| Any Swelling, Booster dose |
|
|
| Any Pain, Across doses |
|
|
| Any Redness, Across doses |
|
|
| Any Swelling, Across doses |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
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